MAUDE Adverse Event Report: CAREFUSION 303, INC. LIMB-O; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number AFNX894C

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2016

Event Type  malfunction  

Event Description

Anesthesia circuit co2 sampling line malfunction.The line is kinked within the tubing because of excess length.This is occurring in about (b)(4) of this particular product.The product should come in working order every time.

• Brand Name: LIMB-O
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION 303, INC.; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 5633444
• MDR Text Key: 44462090
• Report Number: 5633444
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: AFNX894C
• Device Lot Number: 0000899048
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2016
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1